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FDA ANDA · ANDA206886

AUBRA EQ

levonorgestrel and ethinyl estradiol

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA206886
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-14
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AFIRMELLEPrescription
ETHINYL ESTRADIOL 0.02MG, LEVONORGESTREL 0.1MG · TABLET · ORAL-28

Approval history

2022-04-29Labeling · Supplement 2 · standardAP
2017-08-09Labeling · Supplement 1 · standardAP
2016-11-14UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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